Flexible fastening system

ABSTRACT

A flexible implant system includes a flexible implant, an implant housing, and an implant set screw. The flexible implant is configured to loop around a portion of a bony element. The implant housing includes a housing body defining a rod passage configured to receive an rod. The housing body also defines an implant passage that receives a portion of the flexible implant. The implant set screw engages the flexible implant within the implant passage to fix the flexible implant to the implant housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of, and priority to, U.S.Provisional Patent Application Ser. No. 61/775,739, filed on Mar. 11,2013, the entire contents of which is incorporated herein by reference.

BACKGROUND

1. Technical Field

The present disclosure relates to implants and, more specifically, toflexible implant systems for fastening an implant to a bony element.

2. Discussion of Related Art

The spine is made up of a superposition of vertebrae, that are normallyaligned along a vertebral axis, extending from the lumbar vertebrae tothe cervical vertebrae, with each vertebra presenting a posterior wallfrom which there projects a spinous process and two side edges havingwalls from which there project the ribs and/or transverse processes.When an individual's spine presents abnormal curvature, the vertebraeare inclined relative to one another and relative to said vertebralaxis. The lateral edges of the vertebrae situated on one side are thuscloser to one another and form a concave curve, while the lateral edgeson the other side appear spaced apart from one another and form a convexcurve. In order to straighten the spinal column, the lateral edges ofthe vertebrae on the concave side are spaced apart from one another andare taken relative to one another to a distance that is substantiallyequivalent to the distance between the lateral edges on the other side.Thereafter, in order to keep the vertebrae in that position relative toone another, known devices are used that have screws for insertion intothe vertebrae or hooks for inserting along the inside wall of the spinalcanal, associated with rods for interconnecting the screws or the hooks.

The hooks are generally inserted in pairs in each vertebra and on eitherside close to the pedicles, the heads of the hooks projecting from theposterior wall of a vertebra, one on either side of the spinous process.The heads may be tulip-shaped to receive a rod that is secured by meansof a set screw inserted in the head and bearing against the rod. Rowsconstituted by the heads of the hooks situated on either side of thespinous processes are interconnected and held in fixed position by tworods that are parallel to each other and to the axis of the spine.

The use of screws makes it possible to reduce the risks of such surgery.They likewise have tulip-shaped heads and are inserted in pairs in theposterior walls of vertebrae in the pedicles on either side of thespinous processes. The screws constitute fastening points in thevertebrae for holding them relative to one another. The screws areinserted into the pedicles of the vertebrae, and under certaincircumstances, the pedicles may be damaged.

Wires can be used when the pedicles of the vertebrae are relativelysmall. However, often due to the loading on the wire and the smallsurface area of the wire, the wire may pull through the anatomy and thusbecome ineffective.

Therefore, a continuing needs exists for an implant that can address theanatomy correction, including large deformity reductions andtranslations needed, and still maintain the safety of the patient.

SUMMARY

Accordingly, the present disclosure relates to a flexible implant systemthat has a flexible implant with a surface area larger than a surgicalwire to distribute the load of the implant on a bony element therebyreducing forces applied to a specific point of the anatomy and isconfigured to provide fastening points for spinal rods as an alternativeto screws and hooks.

In an aspect of the present disclosure, a flexible implant systemincludes a flexible implant, an implant housing, and an implant setscrew. The flexible implant is configured to loop around a portion of abony element. The implant housing includes a housing body that defines arod passage and an implant passage. The rod passage is configured toreceive a portion of a rod and the implant passage receives a portion ofthe flexible implant. The implant set screw engages the flexible implantto fix the flexible implant relative to the implant housing. The implantset screw may engage the flexible implant when the flexible implant isreceived within the implant passage. The flexible implant system mayinclude a rod set screw configured to engage a rod disposed within therod passage to fix the rod relative to the implant housing. The bonyelement may be a vertebral body.

The flexible implant may include a leader coupled to an end of theflexible implant. The leader may be made of a malleable metal. Theleader may be crimped to the flexible implant. The flexible implant mayinclude a stiffening wire bonded to the flexible implant along a portionof the length of the flexible implant. The stiffening wire may increasethe rigidity of the flexible implant. The stiffening wire may beinternally bonded within the flexible implant along the entire length ofthe flexible implant.

In embodiments, the implant passage may include a first implant passageand a second implant passage orthogonal to the first implant passage.The flexible implant may be received within one of the first implantpassage or the second implant passage. The first implant passage may bein communication with the second implant passage.

In some embodiments, the housing body defines a cutout in communicationwith the rod passage. The cutout may be compressed to secure a rodwithin the rod passage. The flexible implant system may include a rodset screw received within a first opening defined by the housing body.The first opening may be orthogonal to the cutout. The rod set screw maytighten within the first opening to compress the cutout. The housingbody may have an upper body portion positioned on one side of the cutoutand a lower body portion positioned on an opposite side of the cutout.The upper body portion and the lower body portion may move towards oneanother when the cutout is compressed.

In certain embodiments, the flexible implant system includes atensioning instrument configured to tension the flexible implant. Thetensioning instrument may include a tensioning screw and a clampingmechanism. The clamping mechanism has a clamp arm moveable between afree position and a locked position. In the free position, the flexibleimplant is free to slide through the clamping mechanism, and in thelocked position, the flexible implant is fixed relative to the clampingmechanism. The tensioning screw may move the clamping mechanism awayfrom the implant housing to tension the flexible implant when theclamping mechanism is in the locked position.

In aspects of the present disclosure, a method for securing a spinal rodto a bony element includes looping a flexible implant around the bonyelement, positioning an implant housing over the spinal rod such thatthe spinal rod is disposed within a rod passage of the implant housing,fixing the implant housing relative to the spinal rod, passing a portionof the flexible implant through an implant passage defined by thehousing body, tensioning the flexible implant about the bony element,and securing the flexible implant relative to the implant housing. Themethod may include trimming an excess portion of the flexible implantafter securing the flexible implant relative to the implant housing.Tensioning and securing the flexible implant may occur prior to fixingthe implant housing relative to the spinal rod.

Securing the flexible implant may include inserting an implant set screwthrough a second opening defined by the housing body to engage theflexible implant. Looping the flexible implant around the bony elementmay include passing a leader of the flexible implant around the bonyelement and pulling the leader to draw the flexible implant around thebony element.

Tensioning the flexible implant about the bony element may includeengaging the implant housing with a tensioning instrument, slidingportions of the flexible implant through a clamping mechanism of thetensioning instrument, locking the portions of the flexible implantrelative to the clamping mechanism, and rotating a tensioning screw ofthe tensioning instrument to tension the flexible implant.

Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any or all of the other aspectsdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described hereinbelow withreference to the drawings, wherein:

FIG. 1 is a perspective view of a spinal implant system in accordancewith the present disclosure including an implant housing and a flexibleimplant engaged with a spinal rod;

FIG. 2 is a perspective view of the flexible implant of FIG. 1;

FIG. 3 is an exploded view showing the components of the flexibleimplant of FIG. 2;

FIG. 4 is a perspective view of the implant housing of FIG. 1 with theset screws removed from their respective openings;

FIG. 5 is a top view of the implant housing of FIG. 1;

FIG. 6 is a side cross-sectional view taken along section line 6-6 ofFIG. 5;

FIG. 7A is a posterior view of a spinal process of a patient with aspinal rod positioned along the spinal process and the flexible implantof FIG. 2 being threaded around a vertebral body;

FIG. 7B is a lateral cross-sectional view taken along section line 7B-7Bof FIG. 7A;

FIG. 8A is a posterior view of the spinal process of FIG. 7A with theimplant housing of FIG. 4 engaged with the spinal rod;

FIG. 8B is a lateral cross-sectional view taken along section line 8B-8Bof FIG. 8A;

FIG. 9A is a posterior view of a spinal process of FIG. 8A with ends ofthe flexible implant 12 passed through an implant passage in the implanthousing;

FIG. 9B is a lateral cross-sectional view taken along section line 9B-9Bof FIG. 9A;

FIG. 10 is a perspective view of another implant housing in accordancewith the present disclosure including a compressible cutout;

FIG. 11 is a perspective view of the implant housing of FIG. 10 with theset screws removed from their respective openings;

FIG. 12 is a top view of the implant housing of FIG. 10;

FIG. 13 is a cross-sectional view taken along the section line 13-13 ofFIG. 12;

FIG. 14 is a perspective view of yet another implant housing inaccordance with the present disclosure engaged with a spinal rod and theflexible implant of FIG. 2;

FIG. 15 is a cross-sectional view taken along section line 15-15 of FIG.14;

FIG. 16 is a rear perspective view of the implant housing of FIG. 14with the set screws removed from their respective openings and a chockremoved from the implant housing;

FIG. 17 is a cross-sectional view taken along section line 17-17 of FIG.16;

FIG. 18 is a perspective view of a tensioning instrument in accordancewith the present disclosure;

FIG. 19 is an exploded view showing the components of the tensioninginstrument of FIG. 18;

FIG. 20 is a side view of the tensioning instrument of FIG. 18;

FIG. 21 is a cross-sectional view taken along section line 21-21 of FIG.20;

FIG. 22 is a front view of the tensioning instrument of FIG. 18;

FIG. 23 is a side view of the tensioning instrument of FIG. 18 engagedwith the implant housing of FIG. 10 and the flexible implant of FIG. 2illustrating a clamp arm of the tensioning instrument in a freeposition;

FIG. 24 is a side view of the tensioning instrument of FIG. 23 with theclamp arm in a locked position and a head of a tensioning screw adjacenta tensioning body; and

FIG. 25 is a side view of the tensioning instrument of FIG. 24 with theclamp arm in the locked position and the flexible implant tensioned.

DETAILED DESCRIPTION

Embodiments of the present disclosure are now described in detail withreference to the drawings in which like reference numerals designateidentical or corresponding elements in each of the several views. Asused herein, the term “clinician” refers to a doctor, a nurse, or anyother care provider and may include support personnel. Throughout thisdescription, the term “proximal” will refer to the portion of the deviceor component thereof that is closest to the clinician and the term“distal” will refer to the portion of the device or component thereofthat is farthest from the clinician. In addition, the term “cephalad” isused in this application to indicate a direction toward a patient'shead, whereas the term “caudad” indicates a direction toward thepatient's feet. Further still, for the purposes of this application, theterm “lateral” indicates a direction toward a side of the body of thepatient, i.e., away from the middle of the body of the patient. The term“posterior” indicates a direction toward the patient's back, and theterm “anterior” indicates a direction toward the patient's front.Additionally, in the drawings and in the description that follows, termssuch as front, rear, upper, lower, top, bottom, and similar directionalterms are used simply for convenience of description and are notintended to limit the disclosure.

Referring now to FIG. 1 a flexible implant system 10 is provided inaccordance with the present disclosure and includes a flexible implant12 and an implant housing 20. The flexible implant 12 forms a looparound a bony element (see FIG. 7B) of a patient's anatomy and issecured to the bony element by the implant housing 20 as detailed below.Although shown and described in the context of spinal surgery, it iscontemplated that the presently disclosed flexible implant system 10 maybe coupled to other bony elements in a patient. The implant housing 20provides a mounting point for a rod 100. It is within the scope of thisdisclosure that a plurality of flexible implant systems 10 may be usedto provide a plurality of mounting points along a bony element of apatient's anatomy. It is also contemplated that the flexible implantsystem 10 may be used with spinal hooks (not shown) and pedicle screws(not shown) to provide a plurality of mounting points along a bonyelement of a patient's anatomy.

With reference to FIGS. 2 and 3, the flexible implant 12 includes animplant body 14, a leader 16, and a guide wire 18. The implant body 14may be made from various polymers including but not limited to nylon,Dacron®, Ultra-High-Molecular-Weight Polyethylene (UHMWPE),polypropylene, polyester, etc. The implant body 14 may include astiffening wire to increase the stiffness of the implant body 14. Thestiffening wire 15 may be internally bonded (i.e., bonded within theimplant body 14) or may be externally bonded (i.e., bonded on anexternal surface of the implant body 14). The stiffening wire 15 may bebonded along the entire length of the implant body 14 or only a portionof the length of the implant body 14.

The leader 16 may be made of a malleable metal that is attached to anend of the implant body 14. The leader 16 may be attached to implantbody 14 by various techniques including but not limited to crimping,ultrasonic welding, sewing, gluing, etc. The leader 16 may assist ininserting the flexible implant 12 through or around the anatomy of apatient or tensioning the flexible implant 12 as detailed below. Theleader may be made from a radiopaque plastic material.

The guide wire 18 is attached to an end of the leader 16 opposite of theend attached to the end of the implant body 14. In embodiments, theguide wire 18 may be made of polyester or other like material. In someembodiments, the guide wire 18 is made of malleable metal bonded orcrimped to the leader 16. The guide wire 18 is bonded or crimped to theleader 16. The guide wire 18 is flexible to assist in inserting andguiding the flexible implant 12 through or around the anatomy of apatient as detailed below. It is also within the scope of thisdisclosure that the guide wire 18 is attached directly to the end of theimplant body 14 and extends through the leader 16. Moreover, it iscontemplated that the flexible implant 12 does not include a leader 16and that the guide wire 18 is attached directly to the end of theimplant body 14 or that the guide wire 18 is an end of the stiffeningwire 15 extending from the end of the implant body 14.

Referring to FIGS. 4-6, the implant housing 20 includes a housing body21, a rod set screw 25, and an implant set screw 27. The housing body 21defines a first opening 22, a second opening 23, a rod passage 24, andan implant passage 26. The rod passage 24 is sized and configured toreceive a portion of a rod (e.g., spinal rod 100) therein. The rodpassage 24 is in communication with the first opening 22. The rodpassage 24 may be a U-shaped channel through an upper surface of thehousing body 21. The upper portion of the rod passage 24 may form thefirst opening 22. It will be appreciated that implant housing 20 may bepositioned about a rod in situ. The rod set screw 25 is insertablethrough the first opening 22 such that that rod set screw 25 secures therod within the rod passage 24 as detailed below. The implant passage 26is sized and configured to slidably receive the flexible implant 12 andis in communication with the second opening 23. The implant set screw 27is insertable through the second opening 23 such that the implant setscrew 27 secures the flexible implant 12 within the implant passage 26.The set screws 25, 27 may directly engage the rod and the flexibleimplant 12, respectively, to fix the rod and the flexible implant 12relative to the implant housing 20. It will be appreciated that the setscrews 25, 27 may include threads that cooperate with features (e.g.,threads) of the first and second openings 22, 23, respectively, tosecure the rod and the flexible implant 12 within the rod passage 24 andthe implant passage 26, respectively.

Referring to FIGS. 7A-9B, the spinal implant system 10 is positionedabout a vertebral body B of a patient to provide a fastening point for aspinal rod 100. The guide wire 18 of the flexible implant 12 is used toguide the leader 16 and implant body 14 of the flexible implant 12around a portion of the vertebral body B as shown in FIGS. 7A and 7B.The implant housing 20 is positioned about the spinal rod 100 adjacentthe flexible implant 12 with the spinal rod 100 received within the rodpassage 24. The implant housing 20 may be adjusted to a desired positionrelative to the spinal rod 100 and the vertebral body B. The rod setscrew 25 is inserted into the first opening 22 of the implant housing 20and tightened to fix the implant housing 20 relative to the spinal rod100 in the desired position as shown in FIGS. 8A and 8B. Each end of theflexible implant 12 is inserted through the implant passage 26 of theimplant housing 20. The flexible implant 12 is positioned within theimplant passage 26 such that the implant body 14 is positioned aroundthe vertebral body B and received through the implant passage 26 of theimplant housing 20. When the flexible implant 12 is received through theimplant passage 26, the ends of the flexible implant 12 are pulled totension the flexible implant 12 about the vertebral body B as detailedbelow.

When the flexible implant 12 is tensioned about the vertebral body B,the implant set screw 27 is inserted into the second opening 23 andtightened to fully fix the flexible implant 12 to the implant housing20. It is also within the scope of this disclosure that the implant setscrew 27 may be inserted into the second opening 23 and tightened topartially fix the flexible implant 12 to the implant housing 20 beforethe flexible implant 12 is tensioned. After the flexible implant 12 isfully fixed to the implant housing 20, any excess portion of theflexible implant 12 passing through the implant housing 20 may betrimmed with a scissors, shears, or other suitable instrument.

It is also within the scope of this disclosure that the flexible implant12 may be positioned and/or tensioned about the vertebral body B beforethe implant housing 20 is coupled to the rod 100.

With reference to FIGS. 10-13, another implant housing 30 is provided inaccordance with the present disclosure and includes a housing body 31, arod set screw 35, and an implant set screw 37. The housing body 31defines a first opening 32, a second opening 33, a rod passage 34, afirst implant passage 36 a, a second implant passage 36 b, and acompressible cutout 38. The rod passage 34 is sized and configured toreceive a portion of a rod (e.g., spinal rod 100) therein. The rodpassage 34 may be a U-shaped channel through a rear surface 31 a of thehousing body 31. The compressible cutout 38 passes through side surfaces31 c of the housing body 31 substantially orthogonal to the sidesurfaces 31 c. The compressible cutout 38 is between an upper bodyportion 38 a and a lower body portion 38 b of the housing body 31. Thefirst opening 32 passes through the upper and lower surfaces of thehousing body 31 substantially parallel to the rear surface 31 a of thehousing body 31 and passes through the compressible cutout 38. A firstportion 32 a of the first opening 32 is adjacent the upper surface ofthe housing body 31 and defines a first diameter D₁ through the upperbody portion 38 a. A second portion 32 b of the first opening 32 extendsfrom the first portion 32 a, through the compressible cutout 38, andthrough the lower surface of the housing body 31 and defines a seconddiameter D₂ through the lower body portion 38 b. The first diameter D₁is smaller than the first diameter D₁. A landing 39 may be definedbetween the first and the second portions 32 a, 32 b. The second portion32 b may include a threaded portion 32 c in the lower body portion 38 b.The rod set screw 35 is insertable through the first opening 32 suchthat a head 35 a of the rod set screw 35 engages the landing 39 as athreaded portion 35 b of the rod set screw 35 cooperates with thethreaded portion 32 c of the first opening 32. As the head 35 a engagesthe landing 39 the compressible cutout 38 is compressed to reduce adiameter of the rod passage 34 to fix the implant housing 30 to the rodreceived within the rod passage 34. The upper and lower body portions 38a, 38 b are moved towards one another as the compressible cutout 38 iscompressed. This frictional engagement between the rod 100 and theimplant housing 30 secures the axial position of the rod 100 withrespect to the implant housing 30. It will be appreciated that thisfrictional engagement also applies to the housing 20 detailed above.

The first implant passage 36 a passes through the upper and lowersurfaces of the housing body 31 and the second implant passage 36 b issubstantially orthogonal to the first implant passage 36 a passingthrough the side surfaces 31 c of the housing body 31. The first andsecond implant passages 36 a, 36 b are each in communication with thesecond opening 33. The first and second implant passages 36 a, 36 b maybe in communication with one another. The second opening 33 is definedin a front surface 31 b of the housing body 31. As shown in FIGS. 12 and13, the front surface 31 b may be oblique to the rear surface 31 a;however, it is also contemplated that the front surface 31 b may beparallel to the rear surface 31 a. The first and second implant passages36 a, 36 b and the second opening 33 function substantially similar tothe implant passage 36 and the second opening 33 detailed above whileproviding greater flexibility to the positioning of the implant housing30 relative to a flexible implant (e.g., flexible implant 12) and a rod(e.g., spinal rod 100).

With reference to FIGS. 14-17, yet another implant housing 40 providedin accordance with the present disclosure includes a housing body 41, arod set screw 45, an implant set screw 47, and an implant chock 48. Thehousing body 41 defines a first opening 42, a second opening 43, a rodpassage 44, and an implant passage 46. The rod passage 44 is sized andconfigured to receive a portion of a rod (e.g., spinal rod 100) therein.The rod passage 44 is in communication with the first opening 42. Therod passage 44 may be a U-shaped channel through a surface of thehousing body 41. In some embodiments, the first opening 42 is parallelto the surface of the housing body 41 through which the rod passage 44passes as shown in FIG. 17. In other embodiments, a portion of the rodpassage 45 may form the first opening 42. The rod set screw 45 isinsertable through the first opening 42 such that that rod set screw 45secures the rod within the rod passage 44. The rod may be axially androtationally secured within the rod passage 44.

The implant passage 46 is sized and configured to slidably receive theflexible implant 12 and is in communication with the second opening 43.The implant passage 46 may be substantially orthogonal to the secondopening 43 as shown in FIG. 17. The implant chock 48 is positionedwithin the implant passage 46 and aligned with the second opening 43.The implant chock 48 is retained within the implant passage 46 by achock pin 49 passing through side surfaces of the housing body 41 andthe implant chock 48. The implant chock 48 may rotate about the chockpin 49. The implant set screw 47 is insertable through the secondopening 43 such that the implant set screw 47 engages the implant chock48. In some embodiments, a portion of the implant set screw 47 engagesthe chock pin 49 such that the implant set screw 47 is retained withinthe second opening 43 by the cooperation of the chock 48 and the chockpin 49. For example, the implant set screw 47 may include a threadedportion 47 a and an engagement portion 47 b extending from the threadedportion 47 a. The engagement portion 47 b defining recesses 49 a torotatably receive a portion of the chock 48 or the chock pin 49. As theimplant set screw 47 is rotated, the engagement portion 47 b engages thechock 48 to fix the flexible implant 12 between the chock 48 and aportion of the implant housing 41. As the engagement portion 47 bengages the chock 48, the chock 48 may rotate such that a lead portion48 a of the chock 48 is wedged into the flexible implant 12 to preventthe flexible implant 12 from sliding within the implant passage 46. Insome embodiments, the rotation of the chock 48 may permit the flexibleimplant 12 to slide in one direction within the implant passage 46 toapply tension to a portion of the flexible implant 12 positioned about abony element (e.g., in the direction of arrow T in FIG. 15) and preventthe flexible implant 12 from sliding in a second direction opposite thefirst direction within the implant passage 46 (e.g., in the directionopposite that of the arrow T in FIG. 15).

Referring now to FIGS. 18-22, a tensioning instrument 50 may be used inaccordance with the present disclosure to tension the flexible implant12 (FIG. 1) within an implant housing (e.g., implant housings 20, 30, or40). The tensioning instrument 50 includes a tensioning mechanism 51 anda clamping mechanism 60. The tensioning mechanism 51 includes atensioning body 52 defining a longitudinal axis A-A. The tensioning body52 includes arms 53 extending parallel to the longitudinal axis A-A. Thearms 53 terminate in fingers 54 that are configured to engage a portionof the housing as detailed below. The arms 53 may be pivotable away fromthe longitudinal axis A-A to engage the housing and lockable whenengaged with the housing. The tensioning body 52 further defines athreaded hole 55 along the longitudinal axis A-A. The threaded hole 55receives a tensioning screw 56. The tensioning screw 56 includes a head57 adjacent a proximal end thereof and a tensioning disc 58 adjacent adistal end thereof.

The clamping mechanism 60 includes a receiver 62, a clamp base 64, and aclamp arm 66. The receiver 62 defines openings 62 a sized to permit thearms 53 to pass through the receiver 62. A pair of disc pins 63 arereceived within the receiver 62 about the tensioning screw 56 proximalto the tensioning disc 58 such that the tensioning screw 56 is retainedwithin the threaded hole 55 and fixed relative to the receiver 62 asshown in FIG. 21. The clamp base 64 is coupled to the receiver 62 by abase screw 65. The clamp base 64 may include a protrusion 64 a align theclamp base with the receiver 62. The clamp base 64 includes an arm mount64 b configured to pivotally retain the clamp arm 66. A pivot screw 69passes through the arm mount 64 b and the clamp arm 66 to retain theclamp arm 66 to the clamp base 64. The clamp arm 66 includes an implantengagement portion 67 to capture the flexible implant 12 between theclamp arm 66 and the clamp base 64 as detailed below. The implantengagement portion 67 may include teeth.

With reference to FIGS. 23-25, when the flexible implant 12 is loopedaround a vertebral body B (FIG. 9B) as detailed above, the tensioninginstrument 50 may be used to tension the flexible implant 12 before theimplant set screw (e.g., implant set screw 27, 37, 47) is tightened tofix the flexible implant 12. As shown, the tensioning instrument 50 isused with the implant housing 30; however, it should be appreciated thatthe tensioning instrument 50 may be used with any of the implanthousings disclosed herein (e.g., implant housings 30, 30, or 40).

With particular reference to FIG. 23, the fingers 54 of the arms 53engage the implant housing 30 to longitudinally fix the tensioning body52 relative to the implant housing 30. The ends of the flexible implant12 are passed through the first implant passage 36 a of the implanthousing 30 and then passed between the clamp arm 66 and the clamp base64 with the clamp arm 66 in a free position. In the free position, theflexible implant 12 is free to slide between the clamp base 64 and theclamp arm 66. The tensioning screw 56 is rotated until the receiver 62is adjacent the implant housing 30 and the head 57 is adjacent thetensioning body 52.

When the head 57 of the tensioning screw 56 is adjacent the tensioningbody 52, the ends of the flexible implant 12 are held or partiallytensioned as the clamp arm 66 is moved to the clamped position as shownin FIG. 24. In the clamped position, the implant engagement portion 67captures the flexible implant between the clamp arm 66 and the clampbase 64 to prevent the flexible implant 12 from moving relative to theimplant housing 30. With the clamp arm 66 is the clamped position, thetensioning screw 56 is rotated within the tensioning body 52 to move theclamping mechanism 60 away from the implant housing 30 as shown in FIG.25. The tensioning disc 58 of the tensioning screw 56 is fixed relativeto the receiver 62 to move the receiver 62 away from the implant housing30. As the receiver 62 moves away from the implant housing 30, the clampbase 64 moves away from the implant housing to tension the flexibleimplant 12 that is captured by clamp arm 66 and fixed relative to theclamp base 64. When the flexible implant 12 is tensioned, the implantset screw 37 may be tightened to fix the flexible implant 12 relative tothe implant housing 30. When the flexible implant 12 is fixed to theimplant housing 30, the tensioning instrument 50 may be removed from theimplant housing 30.

The tensioning instrument 50 may be removed by trimming the excessportion of the flexible implant 12 as detailed above and removing theexcess portion of the flexible implant 12 with the tensioning instrument50. It will be appreciated, that the tensioning instrument 50 wouldretain the excess portion of the flexible implant 12. The tensioninginstrument 50 may also be removed by releasing the flexible implant 12by returning the clamp arm to the free position before trimming theexcess portion of the flexible implant 12. The excess portion of theflexible implant 12 may include the leader 16.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Any combination ofthe above embodiments is also envisioned and is within the scope of theappended claims. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of particularembodiments. Those skilled in the art will envision other modificationswithin the scope and spirit of the claims appended hereto.

What is claimed:
 1. A flexible implant system comprising: a flexibleimplant configured to loop around a portion of a bony element; animplant housing including a housing body defining a rod passage and animplant passage, the rod passage configured to receive a portion of arod, the implant passage receiving a portion of the flexible implant;and an implant set screw engaging the flexible implant to fix theflexible implant to the implant housing.
 2. The flexible implant systemof claim 1, wherein the implant set screw engages the flexible implantwhen the flexible implant is received within the implant passage.
 3. Theflexible implant system of claim 1, wherein the flexible implantincludes a leader coupled to an end of the flexible implant, the leadermade of a malleable metal.
 4. The flexible implant system of claim 3,wherein the leader is crimped to the flexible implant.
 5. The flexibleimplant of system of claim 1, wherein the flexible implant includes astiffening wire bonded to the flexible implant along a portion of thelength of the flexible implant to increase the rigidity of the flexibleimplant.
 6. The flexible implant of system of claim 5, wherein thestiffening wire is internally bonded within the flexible implant alongthe entire length of the flexible implant.
 7. The flexible implantsystem of claim 1, wherein the implant passage includes a first implantpassage and a second implant passage orthogonal to the first implantpassage.
 8. The flexible implant system of claim 7, wherein the flexibleimplant is received in one of the first implant passage or the secondimplant passage.
 9. The flexible implant system of claim 7, wherein thefirst implant passage is in communication with the second implantpassage.
 10. The flexible implant system of claim 1, wherein the housingbody defines a cutout in communication with the rod passage and thecutout is configured to compress and secure the rod within the rodpassage.
 11. The flexible implant system of claim 10 further comprisinga rod set screw and the housing body defining a first opening orthogonalto the cutout for receiving the rod set screw, the rod set screwcompressing the cutout when tightened within the first opening.
 12. Theflexible implant system of claim 11, wherein the housing body has anupper body portion positioned on one side of the cutout and a lower bodyportion positioned on an opposite side of the cutout, the upper bodyportion moving towards the lower body portion when the rod set screwcompresses the cutout.
 13. The flexible implant system of claim 1further comprising a rod set screw configured to engage a rod disposedwithin the rod passage to fix the rod relative to the implant housing.14. The flexible implant system of claim 1 further comprising atensioning instrument configured to tension the flexible implant, thetensioning instrument including a tensioning screw and a clampingmechanism, the clamping mechanism including a clamp arm having a freeposition, wherein the flexible implant is free to slide through theclamping mechanism, and a locked position, wherein the flexible implantis fixed relative to the clamping mechanism, the tensioning screw movingthe clamping mechanism away from the implant housing to tension theflexible implant when the clamping mechanism is in the locked position.15. A method for securing a spinal rod to a bony element, the methodcomprising: looping a flexible implant around the bony element;positioning an implant housing over the spinal rod such that the spinalrod is disposed within a rod passage of the implant housing; fixing theimplant housing relative to the spinal rod; passing a portion of theflexible implant through an implant passage defined by the housing body;tensioning the flexible implant about the bony element; securing theflexible implant relative to the implant housing.
 16. The method ofclaim 15, wherein securing the flexible implant includes inserting animplant set screw through a second opening defined by the housing bodyto engage the flexible implant.
 17. The method of claim 15 furthercomprising trimming an excess portion of the flexible implant aftersecuring the flexible implant relative to the implant housing.
 18. Themethod of claim 15, wherein looping a flexible implant around the bonyelement includes passing a leader of the flexible implant around thebony element and pulling the leader to draw the flexible implant aroundthe bony element.
 19. The method of claim 15, wherein tensioning theflexible implant about the bony element include engaging the implanthousing with a tensioning instrument, sliding portions of the flexibleimplant through a clamping mechanism of the tensioning instrument,locking the portions of the flexible implant relative to the clampingmechanism, and rotating a tensioning screw of the tensioning instrumentto tension the flexible implant.
 20. The method of claim 15, wherein thetensioning the flexible implant about the bony element and securing theflexible implant relative to the implant housing occurs prior to fixingthe implant housing relative to the spinal rod.